NCLE Study Guide Part 3 out 4 with Complete Solutions!

The FDA (Food and Drug Administration) - ANSWER-? classifies lens material by how much water is in it and by the electronic charge. The water is either low or high, and percentages are given. The electronic charge is indicated with ionic or non-ionic. The materials are in four groups as follows: The FDA classifies lens material by four groups as follows: - ANSWER-Group 1-low water 50% water, non-ionic polymers (this group includes silicone hydrogel polymers) Group 2- high water 50% water, non-ionic polymers Group 3- low water 50% water, ionic polymers Group 4- high water 50% water, ionic polymers The FDA tests disinfectants for their successfulness against these four microorganism groups: - ANSWER-•gram-positive cocci •gram-negative rods •yeast •fungi "disposable lenses" - ANSWER-The FDA classification for ? means the lens is disposed of after removal. extended wear (EW) - ANSWER-The FDA classification for ? is 1 week, Continuous wear (CW) - ANSWER-refers to wearing contact lenses both during the day and while sleeping for periods of up thirty days and nights consecutively; however the FDA still recommends an overnight removal of continuous wear every 6 nights/7 days. Good Manufacturing Practices (GMP) - ANSWER-standards is that part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to thei intended use and as required by the marketing authorization (MA) or product specification. GMP is concerned with both production and quality control. FDA approval for marketing - ANSWER-All materials are tested, evaluated, and quarantined until all of the standards have been met. Lens blanks are inspected, tested, and quarantined until all of the standards are met and documented. Inspection continues to happen through all stages of production. HIPAA - ANSWER-The Health Insurance Portability and Accountability Act of 1996 ("HIPAA") authorized the Department of Health and Human Services to adopt regulations to require certain health providers to limit the use and disclosure of protected health information. The regulations became effective on April 14, 2003. FCLCA - ANSWER-The Fairness to Contact Lens Consumers Act became law on February 4, 2004. The Act mandates that eye care practitioners, including optometrists, release contact lens prescriptions to their patients. It also requires contact lens sellers to verify the validity of contact lens prescriptions before releasing contact lenses to consumers. FTC - ANSWER-The Federal Trade Commission enforces both the Contact Lens Rule and the Eyeglass Rule. These Rules require that eye care providers give their cust